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SPIRIVA RESPIMAT 2.5 MICROGRAMS SOLUTION FOR INHALATION

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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504023/PL1d

PACKAGE LEAFLET: INFORMATION FOR THE USER

Spiriva® Respimat®
2.5 micrograms,
Solution for Inhalation
(tiotropium bromide)
The name of your medicine is Spiriva Respimat 2.5
micrograms, Solution for Inhalation. Throughout this
leaflet it will be referred to as Spiriva Respimat.
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Spiriva Respimat is and what it is used for
2. What you need to know before you take Spiriva
Respimat
3. How to take Spiriva Respimat
4. Possible side effects
5. How to store Spiriva Respimat
6. Contents of the pack and other information

1. What Spiriva Respimat is and what it is
used for
Spiriva Respimat helps people who have chronic
obstructive pulmonary disease (COPD) or asthma to
breathe more easily. COPD is a long-term lung disease
that causes shortness of breath and coughing. The term
COPD is associated with the conditions chronic
bronchitis and emphysema. Asthma is a long-term
disease characterised by airway inflammation and
narrowing of the airways. As COPD and asthma are
long-term diseases you should take Spiriva Respimat
every day and not only when you have breathing
problems or other symptoms. When used to treat asthma
you should use Spiriva Respimat in addition to so-called
inhaled corticosteroids and long-acting ß2 agonists.
Spiriva Respimat is a long-acting bronchodilator that
helps to open your airways and makes it easier to get air
in and out of the lungs. Regular use of Spiriva Respimat
can also help you when you have on-going shortness of
breath related to your disease, and will help to minimise
the effects of the disease on your everyday life. Daily use
of Spiriva Respimat will also help to prevent any sudden,
short-term worsening of your COPD symptoms which
may last for several days.
For correct dosing of Spiriva Respimat please see
section 3. How to take Spiriva Respimat and the
instructions for use provided on the other side of the
leaflet.

2. What you need to know before you take
Spiriva Respimat
Please read the following questions carefully. If you
can answer any of these questions with ‘Yes’ please
discuss this with your doctor before taking Spiriva
Respimat.









are you allergic (hypersensitive) to tiotropium,
atropine or similar drugs such as ipratropium or
oxitropium?
are you taking any other medicinal products
containing ipratropium or oxitropium?
are you pregnant, do you think you are pregnant, or
are you breast-feeding?
are you suffering from blurred vision, eye pain and/
or red eyes, prostate problems or have difficulty
passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during
the last 6 months or from any unstable or life
threatening irregular heart beat or severe heart
failure within the past year?

Do not use Spiriva Respimat
– if you are allergic (hypersensitive) to tiotropium, its
active ingredient or any of the other ingredients of
this medicine (listed in section 6)
– if you are allergic (hypersensitive) to atropine or
substances related to it, e.g. ipratropium or
oxitropium
Warnings and precautions
Talk to your doctor before taking Spiriva Respimat.
When taking Spiriva Respimat take care not to let any
spray enter your eyes. This may result in eye pain or
discomfort, blurred vision, seeing halos around lights or
coloured images in association with red eyes (i.e. narrow
angle glaucoma). Eye symptoms may be accompanied
by headache, nausea or vomiting. Wash your eyes in
warm water, stop using tiotropium bromide and
immediately consult your doctor for further advice.
If your breathing has got worse or if you experience rash,
swelling or itching directly after using your inhaler, stop
using it and tell your doctor immediately.
Dry mouth which has been observed with anticholinergic
treatment may in the long term be associated with dental
caries. Therefore, please remember to pay attention to
oral hygiene.
Spiriva Respimat is indicated for the maintenance
treatment of your chronic obstructive pulmonary disease
or asthma. Do not use this medicine to treat a sudden
attack of breathlessness or wheezing. Your doctor
should have given you another inhaler (“rescue
medication”) for this.
Please follow the instructions your doctor has given you.

If you have been prescribed Spiriva Respimat for your
asthma it should be added on to inhaled corticosteroids
and long-acting ß2 agonists. Continue taking the inhaled
corticosteroids as prescribed by your doctor, even if you
feel better.

3. How to take Spiriva Respimat

Side effect

Always take this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.

In case you have suffered from a myocardial infarction
during the last 6 months or from any unstable or life
threatening irregular heart beat or severe heart failure
within the past year, please, inform your doctor. This is
important to decide if Spiriva is the right medicine for you
to take.

Spiriva Respimat is for inhalation use only.

Dry mouth: this is
usually mild
Dizziness
Headache
Difficulty in sleeping
(insomnia)
Irregular heart beat
(atrial fibrillation,
supraventricular
tachycardia)
Feeling your heartbeat
(palpitations)
Faster heart beat
(tachycardia)
Cough
Nosebleed (epistaxis)
Inflammation of the
throat (pharyngitis)
Hoarseness
(dysphonia)
Tightness of the chest,
associated with
coughing, wheezing or
breathlessness
immediately after
inhalation
(bronchospasm)
Constipation
Fungal infections of
the oral cavity and
throat
(oropharyngeal
candidiasis)
Difficulties swallowing
(dysphagia)
Rash
Itching (pruritus)
Difficulties passing
urine
(urinary retention)
Painful urination
(dysuria)
Seeing halos around
lights or coloured
images in association
with red eyes
(glaucoma)
Increase of the
measured eye
pressure
Blurred vision
Inflammation of the
larynx (laryngitis)
Heart burn
(gastrooesophageal
reflux disease)
Dental caries
Inflammation of the
gums (gingivitis)
Inflammation of the
tongue (glossitis)
Inflammation of the
mouth (stomatitis)

Do not take Spiriva Respimat more frequently than once
daily.
You should also contact your doctor if you feel that your
breathing is worsening.
If you have cystic fibrosis, tell your doctor because
Spiriva Respimat could make your cystic fibrosis
symptoms worse.
Children and adolescents
Spiriva Respimat is not recommended for children and
adolescents under 18 years.
Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including
medicines obtained without a prescription.
In particular, please tell your doctor or pharmacist if you
are taking/have taken anticholinergic drugs, e.g.
ipratropium or oxitropium.
No interaction side effects have been reported when
Spiriva Respimat has been taken with other products
used to treat COPD such as reliever inhalers (e.g.
salbutamol), methylxanthines (e.g. theophylline),
antihistamines, mucolytics (e.g. ambroxol), leukotriene
modifiers (e.g. montelukast), cromones, anti-IgE
treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. You should not
use this medicine unless specifically recommended by
your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use
machines have been performed. In case dizziness or
blurred vision occurs the ability to drive and use
machinery may be influenced.

The recommended dose for adults is:
Spiriva Respimat is effective for 24 hours so you will
need to use Spiriva Respimat only ONCE A DAY, if
possible at the same time of the day. Each time you use
it take TWO PUFFS.
As COPD and asthma are long-term diseases take
Spiriva Respimat every day and not only when you
experience breathing problems. Do not take more than
the recommended dose.
Spiriva Respimat is not recommended for use in children
and adolescents below 18 years due to lack of data on
safety and efficacy.
Make sure that you know how to use your Spiriva
Respimat inhaler properly. The instructions for use of the
Spiriva Respimat inhaler are provided on the other side
of this leaflet.
If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one
day talk to your doctor immediately. You may be at a
higher risk of experiencing a side effect such as dry
mouth, constipation, difficulties passing urine, increased
heart beat or blurred vision.
If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE
A DAY), don’t worry. Take it as soon as you remember
but do not take two doses at the same time or on the
same day. Then take your next dose as usual.
If you stop taking Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk
to your doctor or your pharmacist. If you stop taking
Spiriva Respimat the signs and symptoms of COPD may
worsen.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Evaluation of the side effects is based on the following
frequencies:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the
available data
The side effects described below have been experienced
by people taking this medicine and they are listed
according to frequency as either common, uncommon,
rare or not known.

Frequency
COPD
Common

Frequency
Asthma
Common

Uncommon
Uncommon
Rare

Uncommon
Uncommon
Uncommon

Rare

Not known

Rare

Uncommon

Rare

Not known

Uncommon
Rare
Uncommon

Uncommon
Not known
Uncommon

Uncommon

Uncommon

Rare

Uncommon

Uncommon
Uncommon

Rare
Uncommon

Rare

Not known

Uncommon
Uncommon
Uncommon

Rare
Rare
Not known

Uncommon

Not known

Rare

Not known

Rare

Not known

Rare
Rare

Not known
Not known

Rare

Not known

Rare
Rare

Not known
Rare

Rare

Not known

Not known

Rare

Serious allergic
reaction which causes
swelling of the mouth
and face or throat
(angioneurotic
oedema)
Nettle rash (urticaria)
Infections or
ulcerations of the skin
Dryness of the skin
Hypersensitivity,
including immediate
reactions
Infections of the urinary
tract
Depletion of body
water (dehydration)
Inflammation in sinuses
(sinusitis)
Blockage of intestines
or absence of bowel
movements (intestinal
obstruction, including
ileus paralytic)
Feeling sick (nausea)
Severe allergic reaction
(anaphylactic reaction)
Swelling of joint

Rare

Rare

Rare
Rare

Rare
Not known

Rare
Not known

Not known
Rare

Rare

Not known

Not known

Not known

Not known

Not known

Not known

Not known

6. Contents of the pack and other
information
What Spiriva Respimat contains
The delivered dose is 2.5 micrograms tiotropium (as
bromide monohydrate) per puff (2 puffs comprise one
medicinal dose). One cartridge contains 4.0 ml providing
60 puffs (30 medicinal doses).
The delivered dose is the dose which is available for the
patient after passing the mouthpiece.
The other ingredients are:
Benzalkonium chloride, disodium edetate, purified water
and hydrochloric acid 3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of the
pack
Spiriva Respimat 2.5 microgram is composed of one
cartridge with solution for inhalation and one Respimat
inhaler. The cartridge has to be inserted into the inhaler
before the first use.
Single pack:

Not known
Not known

Not known
Not known

Not known

Not known

Immediate allergic reactions such as rash, nettle rash
(urticaria), swelling of the mouth and face or sudden
difficulties in breathing (angioneurotic oedema) or other
hypersensitivity reactions (such as sudden reduction of
your blood pressure or dizziness) may occur individually
or as part of severe allergic reaction (anaphylactic
reaction) after administration of Spiriva Respimat. If any
of these occur, please consult your doctor immediately.
In addition, in common with all inhaled medicines,
some patients may experience an unexpected tightness
of the chest, coughing, wheezing or breathlessness
immediately after inhalation (bronchospasm).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

1 Respimat inhaler and 1 cartridge,
providing 60 puffs (30 medicinal doses)

Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd, both at
St James’ House, 8 Overcliffe, Gravesend, Kent,
DA11 0HJ.
The manufacturer for Spiriva Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173, D-55216 Ingelheim am Rhein
Germany.
Spiriva® Respimat® 2.5 micrograms, Solution for
Inhalation
PL No: 18067/0405
POM
Spiriva® and Respimat® are registered trademarks of
Boehringer Ingelheim Pharma GmbH & Co. KG
This leaflet was last approved on 26th July 2016.
To request a copy of this leaflet in Braille, large print or
audio please call 01622 690172.

5. How to store Spiriva Respimat
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and on the inhaler label. The expiry
date refers to the last day of the month. Spiriva Respimat
inhaler should be discarded at the latest 3 months after
first use (see Instructions for Use overleaf).
Do not freeze.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

Continued overleaf

Spiriva® Respimat® Inhaler

TWO PUFFS

Instructions For Use

ONCE DAILY

Prepare for first use

How to care for your Spiriva Respimat

Spiriva Respimat (tiotropium bromide). Read
these Instructions for Use before you start using
Spiriva Respimat.

Clean the mouthpiece including the metal part
inside the mouthpiece with a damp cloth or tissue
only, at least once a week.
Any minor discoloration in the mouthpiece does
not affect your Spiriva Respimat inhaler
performance. If necessary, wipe the outside of
your Spiriva Respimat inhaler with a damp cloth.

You will need to use this inhaler only ONCE A
DAY. Each time you use it take TWO PUFFS.
MOUTHPIECE

CAP

When to get a new Spiriva Respimat

1
2

AIR VENT
DOSERELEASE
BUTTON

DOSE
INDICATOR

SAFETY
CATCH

EMPTY

3









FULL

CLEAR
BASE

Keep the cap closed.
Press the safety catch while firmly
pulling off the clear base with your
other hand.

TURN



Insert cartridge
Insert the narrow end of the cartridge
into the inhaler.
Place the inhaler on a firm surface and
push down firmly until it clicks into
place.

PIERCING
ELEMENT






CARTRIDGE

If Spiriva Respimat has not been used for
more than 7 days release one puff towards
the ground.
If Spiriva Respimat has not been used for
more than 21 days repeat steps 4 to 6
under ‘Prepare for first Use’ until a cloud is
visible. Then repeat steps 4 to 6 three
more times.
Do not touch the piercing element inside
the clear base.

4








Your Spiriva Respimat inhaler contains 60
puffs (30 doses) if used as indicated (two
puffs/ once daily).
The dose indicator shows approximately how
much medication is left.
When the dose indicator enters the red area
of the scale you need to get a new
prescription; there is approximately
medication for 7 days left (14 puffs).
Once the dose indicator reaches the end of
the red scale, your Spiriva Respimat locks
automatically – no more doses can be
released. At this point, the clear base cannot
be turned any further.
Spiriva Respimat should be discarded three
months after you have prepared it for first
use, even if it has not been fully used or used
at all.




Keep the cap closed.
TURN the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

“CLICK”

6

Did you accidentally turn the
clear base before inserting
the cartridge? Open the cap,
press the dose-release button,
then insert the cartridge.

Did you turn the clear base?
If not, turn the clear base in a
continuous movement until it
clicks (half a turn).
Is the dose indicator on the
Spiriva Respimat pointing to
zero? The Spiriva Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Spiriva
Respimat inhaler.

Did you turn the clear base
already? If the clear base has
already been turned, follow
steps “OPEN” and “PRESS”
under “Daily Use” to get your
medicine.

The dose indicator on the
Spiriva Respimat reaches
zero too soon.

My Spiriva Respimat sprays
automatically

My Spiriva Respimat doesn’t
spray.

Did you use Spiriva
Respimat as indicated (two
puffs/Once
daily)? Spiriva Respimat will
last 30 days if used at two
puffs once daily.
Did you turn the clear base
before you inserted the
cartridge? The dose indicator
counts each turn of the clear
base regardless whether a
cartridge has been inserted or
not.

Was the cap open when you
turned the clear base? Close
the cap, then turn the clear
base.

Did you insert a cartridge? If
not, insert a cartridge.

Is the dose indicator on the
Spiriva Respimat pointing to
zero? The Spiriva Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Spiriva
Respimat inhaler.

CLEAR BASE

Replace clear base
Put the clear base back into place
until it clicks.

OPEN
OPEN the cap until it snaps fully open.

ARROWS

Turn
Keep the cap closed.
Turn the clear base in the direction
of the arrows on the label until it
clicks (half a turn).

Open
Open the cap until it snaps fully
open.

Press
Point the inhaler toward the ground.
Press the dose-release button
Close the cap.
Repeat steps 4-6 until a cloud is
visible.
• After a cloud is visible, repeat
steps 4-6 three more times.
Your inhaler is now ready to use. These
steps will not affect the number of
doses available.
After preparation your inhaler will be able to
deliver 60 puffs (30 doses).





I cannot turn the clear base.

CAP

CAP


I cannot press the doserelease
button.

ARROWS

PRESS

5

It is difficult to insert the
cartridge deep enough.

Did you insert the cartridge
with the wide end first?
Insert the cartridge with the
narrow end first.


CLEAR BASE

Answers to Common Questions

SAFETY
CATCH

Remove clear base
Introduction

Daily use







DOSE
RELEASE
BUTTON




Breathe out slowly and fully.
Close your lips around the mouthpiece
without covering the air vents. Point your
Inhaler to the back of your throat.
While taking a slow, deep breath through
your mouth, PRESS the dose-release button
and continue to breathe in slowly for as
long as comfortable.
Hold your breath for 10 seconds or for as
long as comfortable.
Repeat TURN, OPEN, PRESS for a total of
2 puffs.
Close the cap until you use your inhaler again.

AIR VENT

Did you spray in the air often
to check whether the Spiriva
Respimat is working? Once
you
have prepared Spiriva
Respimat, no test-spraying is
required if used daily.
Did you insert the cartridge
into a used Spiriva
Respimat?
Always insert a new cartridge
into a NEW Spiriva Respimat.

Did you press the doserelease button when turning
the clear base? Close the
cap, so the dose-release
button is covered, then turn the
clear base.

Did you repeat TURN, OPEN,
PRESS less than three times
after inserting the cartridge?
Repeat TURN, OPEN, PRESS
three times after inserting the
cartridge as shown in the steps
4 to 6 under “Prepare for first
Use”.

Did you stop when turning
the clear base before it
clicked?
Turn the clear base in a
continuous movement until it
clicks (half a turn).

Is the dose indicator on the
Spiriva Respimat pointing to
0? If the dose indicator points
to 0, you have used up all your
medication and the inhaler is
locked.
Once your Spiriva Respimat is
assembled, do not remove the
clear base or the cartridge.
Always insert a new cartridge
into a NEW Spiriva Respimat.

504023/PL1d

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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